Muscle tissue

Longeveron Announces Activation of Two New Clinical Sites in ELPIS II Trial of Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)

Wednesday, October 20, 2021 - 1:30pm

Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured in Longeverons cell processing facility in Miami, Florida.

Key Points: 
  • Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured in Longeverons cell processing facility in Miami, Florida.
  • The HLHS program has transitioned into a Phase 2 trial titled: Evaluation of Lomecel-B Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase 2b Clinical Trial (ELPIS II).
  • Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions.
  • Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimers disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS).

HeartFlow Announces Enrollment of First Two Patients in REVEALPLAQUE Trial

Thursday, October 14, 2021 - 1:00pm

It is clear, however, that coronary plaque is the driving force behind understanding a patients risk of having a heart attack, said Dr. Meckel, lead Principal Investigator for REVEALPLAQUE at Bryan Heart.

Key Points: 
  • It is clear, however, that coronary plaque is the driving force behind understanding a patients risk of having a heart attack, said Dr. Meckel, lead Principal Investigator for REVEALPLAQUE at Bryan Heart.
  • To be able to accurately and non-invasively understand a patients plaque burden would be game changing in physicians abilities to save a patients life from a heart attack.
  • The REVEALPLAQUE trial is planned to enroll 250 patients with stable coronary artery disease from approximately 15 sites across the U.S. and Japan.
  • The HeartFlow FFRct Analysis is commercially available in the United States, UK, Canada, Europe and Japan.

Global Biomaterials Markets Analysis and Forecast, 2021-2031 - ResearchAndMarkets.com

Monday, October 11, 2021 - 5:02pm

The "Biomaterials Market - A Global and Regional Analysis: Focus on Applications, Product Types, and Countries - Analysis and Forecast, 2021-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Biomaterials Market - A Global and Regional Analysis: Focus on Applications, Product Types, and Countries - Analysis and Forecast, 2021-2031" report has been added to ResearchAndMarkets.com's offering.
  • The major categories product by type includes metal-based biomaterials, polymer-based biomaterials, ceramic-based biomaterials, natural-based biomaterials, inorganic glass-based biomaterials, radiopaque biomaterials, regenerative biomaterials, hybrid biomaterial combinations.
  • Which product type is expected to witness the maximum demand growth in the global biomaterials market during the period 2021-2031?
  • What is the competitive strength of the key players in the global biomaterials market based on their recent developments, product offerings, and regional presence?

Fujitsu and University of Tokyo Hospital Embark on Joint Research into AI to Aid the Fight Against Heart Disease

Monday, October 11, 2021 - 2:29am

Since December 2019, Fujitsu has been making progress with research and development of proprietary AI technology(2) in collaboration with the University of Tokyo Hospital.

Key Points: 
  • Since December 2019, Fujitsu has been making progress with research and development of proprietary AI technology(2) in collaboration with the University of Tokyo Hospital.
  • The AI will be used in clinical field research to estimate the presence or absence of abnormal heart movements based on the data of patients undergoing electrocardiographic procedures at the University of Tokyo Hospital.
  • Based on the electrocardiogram data of patients examined at the University of Tokyo Hospital, Fujitsu and the University of Tokyo Hospital will verify the effectiveness of detection of abnormal heart movement by AI.
  • Through its joint research with the University of Tokyo Hospital, Fujitsu will continue to actively promote research and development of AI to detect various heart diseases.

Hyloris Expands Cardiovascular Pipeline with Breakthrough Extended-Release Milrinone Capsule in Late-Stage Heart Failure

Friday, October 8, 2021 - 6:00am

Milrinone is a positive inotrope, a group of heart failure drugs that strengthen the hearts contractions so it can pump more blood with fewer heartbeats.

Key Points: 
  • Milrinone is a positive inotrope, a group of heart failure drugs that strengthen the hearts contractions so it can pump more blood with fewer heartbeats.
  • Milrinone IV is currently approved for use as an intermittent or continuous infusion for treatment of up to 48 hours for acute decompensated heart failure.
  • The current standard of care is predominantly palliative and despite recent advantages with new heart failure therapies, the effectiveness of these is most pronounced in mild to moderate heart failure.
  • 5 The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure.

ZOLL’s TherOx SuperSaturated Oxygen Therapy to Be Highlighted at SCAI Shock Virtual Conference

Tuesday, October 5, 2021 - 2:00pm

ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced that its TherOx SuperSaturated Oxygen (SSO2) Therapy will be the focus of a panel discussion at the upcoming Society for Cardiovascular Angiography & Interventions (SCAI) Shock virtual conference October 7-8.

Key Points: 
  • ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced that its TherOx SuperSaturated Oxygen (SSO2) Therapy will be the focus of a panel discussion at the upcoming Society for Cardiovascular Angiography & Interventions (SCAI) Shock virtual conference October 7-8.
  • SuperSaturated Oxygen (SSO2) Therapy is the first and only FDA-approved treatment to significantly reduce myocardial damage in heart attack patients after percutaneous coronary intervention.
  • SSO2 Therapy was developed by Irvine, California-based TherOx, Inc., now part of ZOLL.
  • TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Friday, October 1, 2021 - 11:59am

Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for mavacamten, an investigational, first-in-class cardiac myosin inhibitor, for the treatment of patients with obstructive hypertrophic cardiomyopathy (obstructive HCM).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for mavacamten, an investigational, first-in-class cardiac myosin inhibitor, for the treatment of patients with obstructive hypertrophic cardiomyopathy (obstructive HCM).
  • Mavacamten could potentially provide a treatment option that addresses the unmet needs of people living with obstructive HCM around the world, said Roland Chen, M.D., senior vice president, Cardiovascular Development, Bristol Myers Squibb.
  • The application is based on the results of the pivotal Phase 3 EXPLORER-HCM trial, which evaluated mavacamten in patients with symptomatic obstructive HCM versus placebo.
  • The EXPLORER-HCM Phase 3 trial enrolled a total of 251 patients with symptomatic (NYHA Class II or III) obstructive hypertrophic cardiomyopathy.

Hassenfeld Children's Hospital at NYU Langone Performs Its First Pediatric Heart Transplant

Wednesday, September 22, 2021 - 12:00pm

NEW YORK, Sept. 22, 2021 /PRNewswire/ -- In a historic first-ever milestone for Hassenfeld Children's Hospital at NYU Langone, a team of pediatric cardiac surgeons successfully replaced the heart of Maz Zisan, an 18-year-old boy from Brooklyn Heights with end-stage heart failure on August 28, 2021.

Key Points: 
  • "Heart transplantation was the only lifesaving option for Maz to have an improved second chance at life," says Rakesh Singh, MD, medical director of the Pediatric Heart Failure and Transplant Program, pediatric cardiologist and associate professor in the Department of Pediatrics at Hassenfeld Children's Hospital at NYU Langone.
  • "The successful completion of our first transplant is a testament to the teamwork within Hassenfeld Children's Hospital at NYU Langone."
  • "He is healthy and home thanks to the excellent care he received at every level especially within the Pediatric Heart Failure and Transplant Program here at NYU Langone.
  • In September 2020, the Pediatric Heart Failure and Transplant Program, part of the Pediatric Congenital Heart Program at Hassenfeld Children's Hospital, was established.

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial

Thursday, September 16, 2021 - 2:05pm

VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received FDA approval for the Investigational Device Exemption (“IDE”) regarding the COSIRA-II IDE Clinical Trial. 

Key Points: 
  • (Neovasc or the Company) ( Nasdaq , TSX : NVCN) announced today that it has received FDA approval for the Investigational Device Exemption (IDE) regardingthe COSIRA-II IDE Clinical Trial.
  • The approval of the supplement is consistent with Neovascs internal target, and the Company remains on track to enroll the first patient in the trial late this year.
  • COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from refractory angina.
  • FDA approval of the IDE Supplement is another important milestone for Neovasc, commented Lisa Becker, Vice President of Regulatory Affairs, Global Angina Therapies, at Neovasc.

HeartFlow Holding, Inc. Provides Selected Preliminary Second Quarter 2021 Financial Results and Updated Guidance for Full Year 2021

Tuesday, September 14, 2021 - 1:00pm

HeartFlow Holding, Inc. (HeartFlow or the Company), the leader in revolutionizing precision heart care, today announced selected preliminary financial results for the period ended June 30, 2021 and provided updated guidance for the year ending December 31, 2021.

Key Points: 
  • HeartFlow Holding, Inc. (HeartFlow or the Company), the leader in revolutionizing precision heart care, today announced selected preliminary financial results for the period ended June 30, 2021 and provided updated guidance for the year ending December 31, 2021.
  • The selected, estimated financial results set forth are unaudited and should be considered preliminary and subject to change.
  • HeartFlow has provided an estimate for the selected, preliminary results described above as the Companys final results remain subject to final adjustments, and managements and the audit committees final reviews.
  • These forward-looking statements include, without limitation, HeartFlows preliminary, estimated results for the period ended June 30, 2021, the projected financial results discussed under the caption FY 2021 Financial Guidance and statements regarding regulatory submissions, guidelines and reimbursement.